BioPharm International, February 2007 - BioPharm International

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BioPharm International, February 2007
Features
Intellectual Property: Patent or Padlock: Patents and Trade Secrets Form the Heart of an Effective IP Strategy
By John M. Garvey , Andrew S. Baluch
Utility patents are granted to anyone who invents any new and useful process, machine, article of manufacture, composition of matter, or any new improvement thereof.
Validation & Compliance: Using Risk Analysis in Process Validation
By Leslie Sidor , Paul Lewus
All of the primary unit operations for cell culture and purification had scores greater than the action threshold.
Outsourcing: Biologics Manufacturing: The CMO Advantage
By Jayant Lakshmikanthan
The changes in biologics manufacturing regulations contained in the 1997 FDA Modernization Act significantly bolstered the growth of CMOs.
Columns and Departments
China Today: Pharmaceutical Distribution in China
By Eliza Yibing Zhou
China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing market segment and a huge population, simply getting pharmaceuticals to the patients and healthcare providers is becoming a daunting task. Biopharmaceuticals distributers face the same challenge, with the added complications associated with cold-chain management, shelf-life, and product stability.
Street Talk: CEO Paychecks: How They Are Determined
By Brian O'Connell
In the September 2006 issue I wrote about the ticklish issue of CEO pay and how shareholder groups, especially the powerful pension and other institutional groups, are growing sick and tired of CEO overpayment and underperformance.
From the Editor: Cloning and Biotech Progress
By Laura Bush
The recent FDA decision that meat from cloned animals is safe for human consumption seems logical enough. A protein is a protein. But even if we can eat such meat, it doesn't necessarily make economic or ecological sense to do so.
Regulatory Beat: Quality Standards to Reshape Manufacturing
By Jill Wechsler
A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight.
Final Word: Should You Need FDA Approval to Make Manufacturing Changes?
By John T. English
The pharmaceutical industry is well aware that FDA is trying to take a risk-based approach to enforcing the current good manufacturing practices (cGMP) regulations. This approach is driven by an economic reality: FDA simply does not have the resources to inspect every facility every other year. The organization doesn't even have the resources to inspect facilities every three years. Likewise, it is not cost-effective for our companies to carry out a complete, documentation-oriented revalidation for every process change, regardless of its significance or risk.

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